OraSure Gets OK for Hepatitis Test

From CDC National Prevention Information Network

June 29, 2010

The U.S. Food and Drug Administration announced Friday it has approved the first rapid-result blood test for the hepatitis C virus. The test is manufactured by OraSure Technologies, which already has approval to sell it in Europe. FDA approved the OraQuick Hepatitis C Rapid Antibody Test for the testing of whole blood drawn from a vein of patients age 15 and older. Unlike existing HCV tests, the OraQuick test strip delivers results in 20 minutes and does not need to be processed by a laboratory. "Approval of OraQuick means that more patients can be notified of their HCV infection faster so that they can consult with their physicians for appropriate health measures," said Jeffrey Shuren, M.D., J.D., director of FDA's Center for Devices and Radiological Health. "Getting faster treatment is an important public health step to control this dangerous disease." The new test should begin shipping to hospitals and other customers by late July or early August, said OraSure CEO Douglas Michels. The company continues to seek approval for similar HCV tests using finger-prick blood samples and oral fluid. To read FDA's announcement, visit www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm217318.htm.

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